Cancer Prevention Pharmaceuticals Announces NEJM Publication of Landmark Phase 3 Clinical Trial for Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, today announced The New England Journal of Medicine (NEJM) has published results from its landmark FAP-310 Phase 3 clinical trial of CPP-1X/sul as a pharmaco-preventive treatment for adults with familial adenomatous polyposis (FAP).

FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. Standard of care is surgery as there are no approved drugs for FAP.

The FAP-310 Phase 3 trial compared the performance of the combination of CPP-1X (eflornithine) and sulindac (CPP-1X/sul), to each single agent alone in delaying progression to an FAP-related clinical event, such as surgery. The trial enrolled 171 patients and was conducted over many years where patients received daily treatment for 2-4 years. It was the largest prospective controlled study ever performed in FAP, and the only clinical event driven trial ever conducted.